This invention relates to a method of extracting compounds from sea buckthorn, to compositions containing that extract, and to the use of those compositions to treat open skin lesions. In particular, it relates to extracting sea buckthorn in vegetable oil in the absence of metals and oxygen.
In 1998 there were over 33 million office visits to dermatologists in the United States, many due to open skin lesions. Elderly people, especially those in nursing facilities, are susceptable to open sores, also called bed sores, pressure ulcers, or decubitus ulcers, and there are an estimated three million pressure sores in the United States each year. For the past several decades, tens of billions of dollars have been spend caring for patients with pressure sores. Despite all of the knowledge generated, the treatment of pressure sores still requires several months, and they frequently become one of the main factors complicating a patient""s life. One of the main functions of the skin is forming a barrier between the organism and the environment. Pressure sores and ulcers disrupt the integrity of the skin and open the gates for the bacterial penetration, leading to secondary infections and reducing life expectancy.
Bedsores are usually caused by reduced blood circulation in limited skin areas. Skin ulcers may be induced by long-term treatment with high doses of steroid hormones and occur as one of the side effects of chemotherapy and radiotherapy. Skin ulcers are one of serious complications of diabetes.
While primary damage may be inflicted by different causes, the healing of skin ulcers, traumatic wounds, burns and other open skin wounds and injuries usually undergo similar sequence of steps that results in restoration of structural integrity of the skin. These steps include wound cleansing, achieved through the influx of inflammatory cell, proliferation of stromal cells to initiate the restorative processes and ingrowth of blood vessels to provide nutritional support for the regeneration. Effective treatment may be expected to promote wound healing through the support of these steps and protection of the area of open injury against bacterial infection and dehydration.
Treatment of open skin sores in elderly patient is further complicated by the reduced rate of regenerative processes, decreased immune system activity, and increased sensitivity to antibiotic therapy. Therefore, topical preparations able to stimulate the regenerating ability of the skin and promote the healing process may assist the healing pressure sores, reduce the probability of secondary infections and improving the quality of patients life overall.
In spite of considerable advances in recent years in the treatment of burns and wounds, the occurrence of bedsores or decubitus ulcers continues to grow. Increases in the number of patients with restricted mobility, which most frequently suffer from bad sores and have the longest recovery period calls for the introduction of new, more efficient, and safe treatments. There are many different products available for the treatment of decubitus ulcers, mostly addressing the issues of prevention and elimination of the bacterial infection and protection against dehydration. Medications with potent antibacterial agents, such as antibiotics, iodine derivatives, hydrogen peroxide, boric acid derivatives etc. are good in protecting against infection, but the occurrence of allergic reactions and skin irritations to these agents may further reduce the rate of skin regeneration, increasing the recovery time, especially in the elderly patients. Medications, comprising synthetic antibacterial agent, hormones, or hormone derivatives, often induce skin sensitization during repetitive applications, usually required for successful treatment of decubitus ulcers. Administration of such medications on the daily basis may cause increasing skin irritation and inflammatory response, especially in elderly patients, interfering with the healing process.
It is a principal object of the present invention to overcome these disadvantages and provide a novel composition suitable for the treatment of open skin lesions, including bedsores or decubitus ulcers.
I have discovered that vegetable oil extracts of sea buckthorn, made in the absence of metals and oxygen, are superior to the same extracts made in the presence of metals or oxygen. Compositions made from the extract not only stimulate and provide the nutrients required for the proliferation of epithelial cells, but also protect the injured area against bacterial infections and dehydration over the course of treatment.
The present invention relates to the method and the compositions for the treatment of skin lesions, such as pressure sores or decubitus ulcers, heat burns, radiation and chemical burns, poor healing wounds and skin damages inflicted by laser or radiation therapy. The composition comprises liposoluble ingredients of sea buckthorn that provide nutrient and increases viability of regenerating cells. The composition may further include a combination of essential oils and herbal extracts, which stimulate regeneration of epidermal cells and have antibacterial properties. The composition is applied topically to the injured skin areas and as a result or repetitive administrations induces and stimulates restorative processes and promotes regeneration of the skin.
The present invention is related to the field of medical treatment of skin conditions, more specifically to a novel composition useful for the treatment and promotion of regeneration of open skin lesions. In particular but not exclusively the invention relates to compositions comprising liposoluble extract of sea buckthorn and its use in the treatment of pressure sores or decubitus ulcers and burns.
In brief, the composition according to the present invention is useful in the treatment of various open lesions of the skin, including open wounds, ulcers, burns, skin damages inflicted by radiation therapy or laser surgery, and in particular the composition is useful in the treatment of bedsores or decubitus ulcers. The composition is formulated as an ointment or lotion and is applied to the site of injury on the regular basis until the integrity of the skin surface is reconstituted. The composition includes liposoluble herbal extracts, essential oils, antioxidant, and vegetable oils. The liposoluble herbal extracts are present in the composition in the amount, which is effective to promote the regeneration of skin cells and provide nutritional support required for epithelial cell regeneration. Essential oils are included in the composition in the amount sufficient to stimulate cell regeneration and provide antibacterial action. Antioxidant is added to increase the stability of the composition and as a source of nutrients for regenerating skin cells. Vegetable oils are used a carrier or diluent and also protect the area of open skin injury against dehydration.
Another main object of this invention is to make available a novel composition useful in the continued and long-term treatment of bedsores or decubitus ulcers without skin sensitization, irritation or induction of adverse reactions of the skin.
A further objective of this invention is to provide a novel composition for the treatment of open skin lesions that stimulates tissue regeneration and promotes the restoration of skin integrity.
Other objective of the present invention is to provide a novel composition combining restorative action with protection against dehydration, and antiseptic effect.
Yet another objective of the present invention is to provide a method for the preparation of the composition for the treatment of open skin lesions.
In this invention an extract is made of the herb, sea buckthorn (Hippophae rhamnoides). A composition is made that includes the extract and the composition is used topically to treat open skin lesions.
An extract is prepared of the berries of sea buckthorn using a vegetable oil as the solvent. The berries should be dried (humidity less than 12 wt %) as moisture interferes with the extraction. Examples of suitable vegetable oils that can be used for the extraction include almond oil, borage oil, canola oil, grape seed oil, jojoba oil, olive oil (virgin olive oil), soybean oil, sunflower oil, wheat germ oil, apricot kernel oil, and mixtures thereof. Olive oil is preferred because of its low viscosity, high stability, negligible occurrence of adverse skin reactions, and low cost. The amount of oil used should be about 2 to about 4 times the weight of ground herbs used; preferably, about 2.5 to about 3.5 times as much oil is used.
During the extraction, metal and oxygen are excluded because they degrade the extract and render it less effective. Metals can be excluded by performing the extraction in a container having a non-metallic internal surface, such as glass or plastic. To prevent the oxidation of the extract, the herbs to be extracted and the vegetable oil are placed in the container and the container is purged with an inert gas to remove the dissolved oxygen. This can be accomplished, for example, by sparging nitrogen into the vegetable oil. While extraction can be performed at room temperature, the mixture is preferably heated to between about 35xc2x0 C. (95xc2x0 F.) and about 65xc2x0 C. (150xc2x0 F.) with periodical shaking, to accelerate the extraction. After about 2 to about 4 days the extraction can be terminated.
The raw extract of liposoluble herbal ingredients is separated from the remaining herb. This can be accomplished, for example, by sedimentation for about 24 to about 48 hours at room temperature or by centrifugation at about 1000 g for about 30 to about 45 minutes at room temperature.
To obtain a higher concentration of the extract, the extraction cycle is preferably repeated 1 to 3 times, each time using the previously-obtained extract as the solvent. The final raw extract can be purified by filtering it at room temperature under a pressure of about 35 to about 200 psi through a series of filters having a pore size of about 8 mkm to about 0.45 mkm (micrometer).
The resulting liposoluble herbal extract is a mixture of many different compounds, some of which have not yet been identified. (Example 1 gives a typical analysis of some of the compounds in the extract.) These compounds are soluble in the vegetable oil, but are either insoluble in water or only slightly soluble in water. The compounds are also soluble in many organic solvents, such as hexane or ethyl acetate.
Other herbs used in the composition of this invention are extracted in the same manner. It is preferable to separately prepare extracts of each herb used, but the herbs can also be mixed and extracted together. If the herbs are extracted together, the mixture of herbs used in the extraction is preferably about 10 to about 50 wt % sea buckthorn and about 50 to about 90 wt % other herbs.
The composition of the this invention includes about 5 to about 95 wt % of the liposoluble herbal extracts of sea buckthorn fruit, obtained in the absence of oxygen and metals. Less extract is less effective and more extract reduces the amount of other active components in the composition. Preferably, the composition contains about 15 to about 40 wt % of the sea buckthorn extract.
To further promote skin regeneration, the composition also preferably contains about 5 to about 95 wt %, and preferably about 15 to about 40 wt %, of the liposoluble herbal extract of at least one other herb. Examples of other herbs that can also be used include rose hips (Rosa species), St. John""s wort (Hypericus perforatum), chickweed herb (Stellaria media), plantain herb (Plantago major), and calendula flowers (Calendula officinalis). Plantain is especially preferred as an additional herb for extraction. Generally, the plant itself or the leaves are used, but for rose hips, rose hips are used and for calendula the flowers are used.
To help promote healing and restorative processes, prevent infection, and inhibit inflammation, the composition also preferably includes about 0.01 to about 10 wt % (preferably about 1.0 to about 4.0 wt %) of at least one essential oil. Essential oils are volatile oils obtained from odoriferous plants. Examples of essential oils that can be used include bergamot (Citrus bargamia), cade (Juniperus oxicedrus), clove (Eugenia cariophyllata), frankincense (Boswelia cartery), geranium (Pelargonium graveolence), helichrysum (Helichrisum angustifolium), lavender (Lavandula angustifolia, lavandula officinalis), myrrh (Commiphora myrrha), niaouli (Melaleuca viridiflora), oregano (Origanum vulgare), palmarosa Cymbopogon martini), patchouli (Pogostemon cablin), rose (Rosa damascena, Rosa mosqueta, Rosa centifolia), rosewood (Aniba rosaeodora), sandalwood (Santalum album), tea tree oil (Melaleuca alternifolia), thyme (Thymus vilgaris), and ylang-ylang (Cananga odorata), and mixtures thereof. The preferred essential oils are helichrysum, palmarosa, frankincense, and geranium.
The composition also preferably contains an antioxidant, which increases the stability of the composition, protects the other ingredients from oxidation, and provides nutrients to support skin regeneration. The amount of antioxidant should be about 1 to about 15 wt %, as more antioxidant is unnecessary and less antioxidant is less effective; the preferred concentration of antioxidant is about 5 to about 10 wt %. Examples of antioxidants that can be used include natural tocopherols and tocotrienols, more specifically vitamin E-1000 IU oil, Vitamin E98 oil, palmvitee, natural vitamin E T-50 oil, and mixtures thereof. Vitamin E oil is the preferred antioxidant. Natural vitamin E oil (hereby referred to as Nat. vit. E), is a concentrate of natural mixed tocopherols in the oil form. Each gram of Natural vitamin E oil contains 500 mg of total tocopherols. The relative amounts of d-alpha, d-beta, d-gamma and d-delta tocopherols in the oil may vary to a certain extend, because of variability of the natural oil. At the same time, the following values, expressed as a percent of the total tocopherols, are typical: d-alphaxe2x80x9414%, d-betaxe2x80x941%, d-gammaxe2x80x9462%, d-deltaxe2x80x9423%.
The composition also preferably contains about 5 to about 80 wt % (preferably about 10 to about 40 wt %) of a diluent to reduce the concentration of the other components to change the viscosity of the composition and to support skin regeneration. The vegetable oils used in the extraction can be used as diluents, as can some other vegetable oils, including avocado oil, black currant oil, borage oil, carrot oil, coconut oil, cocoa butter, evening primrose oil, and mango butter. The preferred diluents are almond oil, carrot oil, or mixtures thereof.
The composition can be formulated as an oil, serum, ointment, lotion, or cream by using thinner or thicker oils in the extraction or as diluents. For example, increasing the percentage of avocado oil or jojoba oil will decrease the liquidity of the composition from an oil to a serum. Increasing the percentage of cocoa butter or coconut oil will further decrease liquidity to an ointment or cream.
Open skin lesions in humans or animals can be treated using a composition according to this invention by applying the composition to the area of the lesion. Examples of such open skin lesions include bed sores (decubitus ulcers), venous stasis ulcers, diabetic ulcers, traumatic wounds, poorly healing wounds, sun burns, heat burns, chemical burns, lacerations, and skin injury induced by radiation therapy or laser surgery. The area of the lesion is cleaned and the composition is applied to it once or twice a day until it has healed, which may require about 3 to about 8 weeks.